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Acetazolamide (Acetazolamide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. AcetaZOLAMIDE is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.

DOSAGE AND ADMINISTRATION

Glaucoma

AcetaZOLAMIDE should be used as an adjunct to the usual therapy. The dosage employed in the treatment of chronic simple (open-angle) glaucoma ranges from 250 mg to 1 g of AcetaZOLAMIDE per 24 hours, usually in divided doses for amounts over 250 mg. It has usually been found that a dosage in excess of 1 g per 24 hours does not produce an increased effect. In all cases, the dosage should be adjusted with careful individual attention both to symptomatology and ocular tension. Continuous supervision by a physician is advisable.

In treatment of secondary glaucoma and in the preoperative treatment of some cases of acute congestive (closed-angle) glaucoma, the preferred dosage is 250 mg every four hours, although some cases have responded to 250 mg twice daily on short-term therapy. In some acute cases, it may be more satisfactory to administer an initial dose of 500 mg followed by 125 or 250 mg every four hours depending on the individual case. Intravenous therapy may be used for rapid relief of ocular tension in acute cases. A complementary effect has been noted when AcetaZOLAMIDE has been used in conjunction with miotics or mydriatics as the case demanded.

Epilepsy

It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of carbonic anhydrase in the central nervous system or whether they are due to the slight degree of acidosis produced by the divided dosage. The best results to date have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adult, in other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns, etc. The suggested total daily dose is 8 to 30 mg per kg in divided doses. Although some patients respond to a low dose, the optimum range appears to be from 375 to 1000 mg daily. However, some investigators feel that daily doses in excess of 1 g do not produce any better results than a 1 g dose. When AcetaZOLAMIDE is given in combination with other anticonvulsants, it is suggested that the starting dose should be 250 mg once daily in addition to the existing medications. This can be increased to levels as indicated above.

The change from other medications to AcetaZOLAMIDE should be gradual and in accordance with usual practice in epilepsy therapy.

Congestive Heart Failure

For diuresis in congestive heart failure, the starting dose is usually 250 to 375 mg once daily in the morning (5 mg/kg). If, after an initial response, the patient fails to continue to lose edema fluid, do not increase the dose but allow for kidney recovery by skipping medication for a day. AcetaZOLAMIDE yields best diuretic results when given on alternate days, or for two days alternating with a day of rest.

Failures in therapy may be due to overdosage or too frequent dosage. The use of AcetaZOLAMIDE does not eliminate the need for other therapy such as digitalis, bed rest, and salt restriction.

Drug-Induced Edema

Recommended dosage is 250 to 375 mg of AcetaZOLAMIDE once a day for one or two days, alternating with a day of rest.

Acute Mountain Sickness

Dosage is 500 mg to 1000 mg daily, in divided doses using tablets or sustained-release capsules as appropriate. In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1000 mg is recommended. It is preferable to initiate dosing 24 to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms.

Note: The dosage recommendations for glaucoma and epilepsy differ considerably from those for congestive heart failure, since the first two conditions are not dependent upon carbonic anhydrase inhibition in the kidney which requires intermittent dosage if it is to recover from the inhibitory effect of the therapeutic agent.

HOW SUPPLIED

AcetaZOLAMIDE tablets, USP are supplied as follows:

AcetaZOLAMIDE tablets 125 mg, white, round, scored, debossed MP 65

Bottles of 20 unit of use              NDC 53489-166-60

Bottles of 50                                 NDC 53489-166-02

Bottles of 100                               NDC 53489-166-01

Bottles of 250                               NDC 53489-166-03

Bottles of 500                               NDC 53489-166-05

Bottles of 1000                             NDC 53489-166-10

AcetaZOLAMIDE tablets 250 mg, white, round, scored, debossed MP 141

Bottles of 50                                 NDC 53489-167-02

Bottles of 100                               NDC 53489-167-01

Bottles of 250                               NDC 53489-167-03

Bottles of 500                               NDC 53489-167-05

Bottles of 1000                             NDC 53489-167-10

Store at controlled room temperature 15°- 30°C (59°- 86°F). [see USP]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured By:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Rev: September 2001 Ch

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